Senior Manufacturing Engineer - Medical Device

RESPONSIBILITIES:
Kforce has a client that is seeking a Senior Manufacturing Engineer - Medical Device. We are working directly with the hiring manager on this search. The company offers a competitive compensation package including base salary, annual bonus, and equity. This position is fully onsite in Carlsbad, CA.

Summary:
The Senior Manufacturing Engineer will lead both new product introduction (NPI) and sustaining manufacturing activities for electro-mechanical based medical devices. This role is responsible for designing, developing, implementing, and controlling robust manufacturing processes that meet quality, regulatory, and business requirements. This position provides hands on technical leadership while influencing suppliers, internal stakeholders, and manufacturing teams.

Key Responsibilities:
* Lead the development, implementation, and optimization of manufacturing processes for both new and existing console medical devices
* Partner closely with global suppliers to define and evaluate manufacturing processes, equipment, tooling, and fixtures to ensure consistent product quality
* Plan and execute characterization studies, Design of Experiments (DoE), and process validations (IQ, OQ, PQ)
* Develop and maintain manufacturing documentation, including work instructions, BOMs, routers, FMEAs, DMRs, and DHF documentation
* Provide technical leadership to engineers and technicians supporting manufacturing operations
* Design and introduce innovative processes, tooling, fixtures, and automation solutions
* Train and guide manufacturing personnel on new processes, equipment, and standards
* Drive functional excellence initiatives across product, process, and technical development
* Track performance against KPIs and lead continuous improvement initiatives
* Support departmental budget planning, resource allocation, and project scheduling

REQUIREMENTS:
* Bachelor's degree in Engineering (Mechanical, Electrical, or related discipline preferred)
* 6-8+ years of manufacturing or process engineering experience in a regulated environment; Specifically in medical device industry (pharmaceutical experience may be considered)
* Hands on experience supporting both New Product Introduction (NPI) and sustaining manufacturing for medical devices
* Experience with electronic and/or electromechanical medical devices or capital medical equipment
* Strong background in DFM/DFA/DFMAT, Lean Manufacturing, DoE, process transfer, PFMEA, and structured problem-solving methodologies
* Familiarity with all phases of Design Controls
* Solid understanding of medical device Quality Management Systems and FDA regulations
* Excellent written and verbal communication skills with strong organizational abilities
* Thrives in a fast paced, cross-functional environment
* Six Sigma certification preferred
* Experience with CAD software; SolidWorks or equivalent preferred

The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.

Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.

This job is not eligible for bonuses, incentives or commissions.

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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